CN108495681B

CN108495681B - Catheter assembly

Info

Publication number: CN108495681B
Application number: CN201680029557.5A
Authority: CN
Inventors: R·M·希克莫特; M·沃拉伯; M·B·博格
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2015-06-26
Filing date: 2016-06-24
Publication date: 2021-07-13
Anticipated expiration: 2036-06-24
Also published as: CA2989055A1; EP3313494A1; US20180169377A1; DK3313494T3; RU2017143998A; RU2719933C2; WO2016206701A1; BR112017025205B1; BR112017025205A2; EP3313494B1; CN108495681A; US11738169B2; US20200345977A1; AU2016283336B2; JP6810061B2; HUE043336T2; EP3590573A1; AU2016283336A1; JP2018518278A; CA2989055C

Abstract

The invention provides a catheter assembly with a cannula. The catheter assembly comprising: a catheter (2) with a hydrophilic surface, said catheter being provided with an insertion tip (5) at its proximal end and an outlet (4) at its distal end; a handle (8) slidably arranged on the catheter; a collapsible flexible sleeve (7) attached to the handle and configured for covering the catheter in an extended configuration of the catheter assembly from the outlet to the tip section, the sleeve being attached to a connector (9) at the outlet, the connector and handle being configured for detachable attachment to each other and defining a cavity provided by the sleeve, handle and connector, thereby enclosing the entire catheter in a stored state.

Description

Catheter assembly

Technical Field

The present invention relates to a catheter assembly comprising a sleeve.

Disclosure of Invention

The present invention relates to a catheter assembly comprising a catheter having a hydrophilic surface. The near end of the catheter is provided with an insertion end head, and the far end of the catheter is provided with an outlet. A handle is slidably disposed on the urinary catheter, and a collapsible flexible sleeve is attached to the handle and configured for covering the urinary catheter in an extended configuration from the outlet to the insertion tip. The sleeve is attached to a connector at the outlet, the connector and handle being configured to detachably attach to each other such that in a storage state when the connector and handle are attached to each other the urinary catheter is fully enclosed in a cavity provided by the sleeve, handle and connector.

Drawings

The accompanying drawings are included to provide a further understanding of the embodiments, and are incorporated in and constitute a part of this specification. The drawings illustrate various embodiments and together with the description serve to explain the principles of the embodiments. Many of the other embodiments and the intended advantages of the embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

Fig. 1 illustrates an embodiment of a catheter assembly in a ready-to-use configuration.

Fig. 2 illustrates a top view of an embodiment of a catheter assembly in a storage configuration.

FIG. 3 illustrates a cross-sectional view of an embodiment of the catheter assembly in a storage configuration.

Fig. 4 shows an embodiment of a urinary catheter in a storage package.

Fig. 5 shows a side view of a detail of an embodiment of the attachment between the handle and the connector in the storage state.

Fig. 6 illustrates a cross-sectional view of a detail of an embodiment of the attachment between the handle and the connector in an attached configuration.

Fig. 7 shows a side view of a detail of an embodiment of the handle and connector in an unattached configuration.

Fig. 8 shows a cross-sectional view of a detail of an embodiment of the attachment between the handle and the connector in an unattached configuration.

Fig. 9 shows a cross-sectional view of a detail of an embodiment of the attachment between the handle and the connector in an unattached configuration.

FIG. 10 illustrates a side view of an embodiment of the catheter assembly in a rolled configuration in a storage package.

FIG. 11 illustrates a side view of an embodiment of a catheter assembly in a rolled configuration.

Fig. 12 illustrates a perspective view of an embodiment of a urinary catheter in a use state.

Fig. 13 and 14 show cross-sectional views of details of an embodiment of the drain structure.

Detailed Description

Catheter assemblies for voiding the bladder are increasingly being used for intermittent as well as indwelling or permanent catheterization. Typically, patients suffering from urinary incontinence or disabled individuals (like paraplegics or quadriplegia) use urinary catheters, and these individuals may lose control of allowing spontaneous urination and for them catheterization may be the way of urination.

Urinary catheters are divided into two main groups of catheters, namely indwelling catheters and intermittent catheters. Indwelling catheters are typically inserted into the urethra and bladder by medical personnel (i.e. trained professionals, usually nurses or doctors) and have means for retaining the catheter within the bladder for up to two weeks or more. Indwelling catheters are soft and flexible, as they must remain in the urethra for several weeks. The indwelling catheter empties the bladder continuously.

Intermittent catheters are typically inserted by the user himself and are only located in the urethra and bladder for the time it takes to empty the bladder continuously, e.g. about 5-10 minutes. The intermittent catheter is used every 4-6 hours to empty the bladder, roughly corresponding to the time interval during which a person without urinary problems would normally go to the restroom. Intermittent catheters are generally more rigid than indwelling catheters because they must be inserted by the user himself, and because they do not need to be located in the urethra for days or weeks. An important feature of intermittent catheters is their ease of insertion into the urethra. This is accomplished by providing an intermittent catheter with a low friction surface. A low friction surface can be obtained by providing an intermittent urinary catheter with a hydrophilic coating that needs to be wetted before use and thereby absorb large amounts of liquid. Such a hydrophilic coating will provide a very smooth surface with very low friction when inserted into a catheter. Hydrophilic coated catheters (where the coating absorbs large amounts of liquid for a low friction surface) (swelling > 100%) will not be suitable for indwelling catheters, because the hydrophilic surface coating will stick within the urethral mucosa if left in the body for a longer period of time, due to the transition from highly smooth when fully wetted to viscous when the hydration level of the coating is reduced.

The catheter is configured for intermittent use and is provided with a hydrophilic surface.

Embodiments relate to a catheter assembly comprising a catheter having a hydrophilic surface, the catheter having an insertion tip at a proximal end of the catheter and an outlet at a distal end of the catheter; a handle slidably disposed on the urinary catheter; a collapsible flexible sleeve attached to the handle and configured to cover the urinary catheter in an extended configuration from the outlet to the insertion tip, the sleeve attached to a connector at the outlet, the connector and handle configured to detachably attach to each other such that when the connector and handle are attached to each other, the urinary catheter is fully enclosed in a cavity provided by the sleeve, handle and connector.

Configured for covering the urinary catheter from the outlet to the insertion tip means that the sleeve covers a substantial part of the longitudinal extent of the catheter in an extended configuration. The connector and handle are typically attached to each other in a storage state, and in this storage state the catheter is fully enclosed within the cavity provided by the sleeve, handle and connector. In the use or extended configuration of the assembly, the connector and handle are separated from one another and the liquid is typically drained from the cavity. The storage state may also be referred to as a closed configuration of the catheter assembly, and the use state may be referred to as an open configuration of the catheter assembly.

One advantage of the catheter assembly is that the sleeve, connector and handle provide a complete enclosure (cavity) for the catheter, so that in the storage state the sterility is not compromised in any way even if the catheter assembly is removed from the optional storage package. The user can discard the assembly on the floor or even in a toilet without compromising the sterility of the catheter itself. In particular, the insertion tip is protected from contamination by contact with any dirty objects as long as the connector is connected to the handle. In addition, when using the catheter, the user simply separates the connector from the handle. After the catheter assembly is opened or deployed, the catheter is ready for use. The sleeve additionally provides the user with the possibility to grip and hold the catheter, making it easier to use. Thereby, the catheter itself may be made of a softer and more bendable material than the catheter to be inserted in a straight position.

In the above described catheter assemblies, the user of the assembly only has to handle one item. Users of catheter assemblies may have reduced hand dexterity making it difficult for them to handle several items. Thus, it may be an advantage not to have to handle additional items (e.g., a lid or closure). Further, when the connector and handle are separated, each of these two portions provides an intuitive location for handling the catheter, which can be done without compromising the sterility of any portion of the catheter.

In the following, whenever reference is made to the proximal end of an element of the invention, this refers to the end adapted for insertion. Whenever reference is made to the distal end of an element, it is meant the end opposite the insertion end. In other words, the proximal end is the end closest to the user when the catheter is to be inserted, while the distal end is the opposite end, i.e. the end furthest from the user when the catheter is to be inserted. The same definition applies to packages and containers, i.e. the proximal end is the end of the proximal end where the catheter is stored, and the distal end is the opposite end.

The longitudinal direction is the distal to proximal direction. The transverse direction is a direction perpendicular to the longitudinal direction, which corresponds to a direction transverse to the axis of the catheter.

The urinary catheter comprises a main tubular portion extending from a distal end to a proximal end. The tip portion is located at the proximal end of the catheter and includes an eyelet portion having an eyelet and a proximal portion adjacent the eyelet portion. The proximal portion may comprise a rounded closed proximal end of the tubular portion. The eyelet may serve the purpose of allowing urine to enter the lumen of the tube. The tip portion may be a pull-in type (Nelaton) tip in which the proximal end is simply closed, thereby providing a hemispherical closed end. The tip portion may be integrally formed with the main tubular portion (either as a 1-part or 2-part molding), or may be provided as a separate element and then attached to the main tubular portion, for example by welding or adhesion. The tip portion may also be made by modifying the main tubular portion by punching out the hole and rounding off the proximal end to close it.

The catheter may be made of Polyurethane (PU) or polyvinyl chloride (PVC) or polyolefins such as Polyethylene (PE).

Urinary catheters typically used for intermittent use range from 8FR sizes to 18FR sizes. FR (or french size or charriere (ch)) is a standard gauge of the catheter, roughly corresponding to the outer circumference (mm). More precisely, the outer diameter mm of the catheter corresponds to FR divided by 3. Thus, 8FR corresponds to a catheter having an outer diameter of 2.7mm, while 18FR corresponds to a catheter having an outer diameter of 6 mm.

The urinary catheter of the invention has a hydrophilic surface giving low-friction insertion and may be provided with a hydrophilic coating before use.

The hydrophilic coating may be provided only on the insertable part of the catheter. Hydrophilic surface coatings are of the following kind: when hydrated or swollen with a swelling medium, reduces friction on the surface area of the catheter corresponding to the insertable part of the catheter intended to be inserted into the urinary channel of the user.

Intermittent hydrophilic catheters differ from indwelling catheters in that the hydrophilic surface coating of such catheters is not suitable for indwelling use because if left in the body for a period of time exceeding 5-20 minutes, the surface coating tends to stick within the urethral mucosa due to the conversion of the hydrophilic coating from highly lubricious when fully wetted (95% water by weight) to tacky when the hydration level of the coating is reduced (< 75% water by weight).

In the stored state, the catheter assembly includes a medium for activating the hydrophilic surface coating of the catheter. The activation medium may be a water-based substance such as sterile water or saline solution.

In an embodiment, the catheter is a male catheter, meaning that the catheter has an insertion length of at least 250mm, more preferably at least 300 mm.

At its proximal end, the cannula is connected to a handle. At its distal end, the cannula is connected to a connector. This ensures that the entire catheter is protected from external bacteria.

In an embodiment, the connector and the handle are provided with interlocking means.

In an embodiment, the interlock is in the form of a threaded coupling. The threads may be short so that the user need only turn the handle and connector about 90 degrees or even less, such as 60 degrees, to disconnect the handle and connector from each other. The threaded coupling has the advantage of being easy to use even for users with poor manual dexterity.

In an embodiment, a kit of parts is provided having the above-described catheter assembly, a tube incorporating a urine collection bag and a connector connecting the urine collection bag to the catheter assembly. The catheter assembly is provided with interlocking means in the form of a threaded coupling and the tube is provided with a threaded coupling adapted to cooperate with the threaded coupling on the connector. Such a threaded coupling may be used to provide a secure connection between the catheter and the tubing connecting the urine collection bag to the catheter. A user may experience that a urine collection bag coupled to a catheter may be accidentally disconnected and thus urine leaks out onto clothing or the floor. This disadvantage can be alleviated by using a threaded coupling in the connector and providing the urine collection bag with a corresponding threaded coupling at the connecting tube.

In an embodiment, the interlocking means are provided as first snap-fit means on the connector and second snap-fit means on the handle, the first and second snap-fit means being complementary snap-fit means. This is a simple and well-functioning way of detachably connecting the connector and the handle to each other. The snap-fit means may be provided as an annular and radially inwardly extending ridge inside the connector adapted for mating with an annular groove on the outer surface of the handle. However, other means such as resilient blades cooperating with grooves may be used.

In some embodiments, an interlock between the connector and the handle may allow reclosing of the catheter assembly after use, as will be explained later. For example, a threaded coupling allows for opening and reclosing of the sleeve. Similarly, a snap-fit coupling may also allow for opening and reclosing of the sleeve. In other words, embodiments relate to the above catheter assembly, wherein the cannula is closable.

The reclosable product allows the catheter to be sanitized throughout the process and removed from the storage package for disposal of the product.

In an embodiment, the connector is configured to receive and protect a tip portion of the catheter.

The connector may be made of a rigid material so that the insertion tip may be protected within the connector when the connector is connected to the handle. Thus, in the storage state, the catheter assembly may be in the form of a ring assembly, completely contained within the cavity provided by the sleeve, the handle and the connector. A flexible insertion tip portion (meaning a readily bendable tip portion) may be susceptible to permanent deformation during storage unless it is ensured that the tip portion is prevented from bending during storage. This is achieved by providing a connector of relatively rigid material such that the storage cavity provides protection against bending of the tip portion.

In an embodiment, the cannula is liquid impermeable and configured for storing liquid in a cavity provided by the cannula, the handle and the connector. This means that the swelling medium or activation medium required for the hydrophilic coating can be contained within the cannula so that the hydrophilic surface on the catheter is activated by the liquid. The material for the sleeve may for example be a foil material of polyethylene, soft polyethylene like LDPE. The material may also be a vinyl plastomer. It is envisaged that a material having a flexural modulus of less than 300MPa measured according to ISO 178 will be sufficiently foldable. By sufficiently collapsible, it is meant that the sleeve provides only minimal resistance against folding towards the distal end. Thus, a sleeve material having a flexural modulus of less than 100MPa may also be used. The sleeve provides an antimicrobial barrier.

One advantage of storing the liquid within the cavity provided by the cannula, handle and connector may be that the outer surface of the cannula is dry.

Embodiments relate to a kit of parts comprising the above-described assembly and a storage package of water-vapor impermeable material. The storage package provides a closure for a catheter assembly comprising a sleeve, a handle, a connector, and a catheter.

By impermeable to water vapour is meant that the material has such a low permeability to water vapour that the catheter assembly can be stored in a storage package wherein the coating is maintained in a fully hydrated state for storage times of up to 3 years. As an example, the material used for the storage package is a foil package comprising a laminate of a thermoplastic material and aluminum, for example a laminate of PETP polyester as the outer layer, an inner layer of aluminum and polyethylene as the intermediate layer. Such a foil package may be provided on a sheet which is folded and welded or glued along the edges to provide a closure. Such a foil package may also be provided on two sheets which are stacked on top of each other and welded or glued along the edges to provide an enclosure. As another example, the storage package is a rigid box injection molded from polypropylene or polyethylene having a thickness of about 0.7mm or greater. Such a hard case may be provided with a lid that is integral with or separate from the remainder of the hard case and provides an enclosure within its interior.

In an embodiment, the storage package of water vapor impermeable material includes a plurality of catheter assemblies. As an example, the storage package includes 5-6 catheter assemblies, such that a user has the number of catheters to be used during a day in one storage package. This is possible because the sleeve comprises a swelling medium and the catheter can be stored in a hydrated or swollen state for at least 24 hours. Thus, the storage wrapper provides the water vapour impermeability required for long term storage (e.g. 3 years), and the sleeve provides the water vapour impermeability required for approximately one or two days.

The storage package may be reclosable regardless of whether the storage package is provided for storing one or more conduits. If the storage package is provided as a foil package, it may be provided with a peelable opening and a resealable adhesive tape that allows the storage package to reseal the opening. Where the storage package is provided as a hard box, the storage package may be resealed by reclosing the lid.

In an embodiment, the tip portion is a flexible tip. In an embodiment of this type, starting from the distal end of the tip section, the tip section of the urinary catheter comprises: an eyelet portion having an eyelet for passing urine into an inner lumen of a catheter; an intermediate portion in which the diameter of the conduit is reduced relative to the diameter of the remainder of the conduit; and a proximal portion having a bulb with a diameter that approaches or exceeds the diameter of the tubular portion of the catheter. The ball may also have a diameter slightly smaller than the diameter of the tubular portion of the catheter. The shape of the ball may be nearly spherical or may be slightly elongated and shaped as an olive or a drop. This type of tip portion may be useful for male users to guide a catheter around a bend in the urethra at the prostate. The catheter assembly described above allows the tip portion to be protected from bending within the connector. The flexible tip portion is adapted to be readily bendable and, due to the viscoelastic properties of the material, will have a tendency to permanently deform into a bent position if subjected to prolonged bending. This means that such bending in the tip section may be difficult, if not impossible, to straighten again when using the catheter. Thus, it would be difficult to insert the catheter into the straight portion of the urethra.

The eyelet affects the bending stiffness of the catheter in such a way that the eyelet portion will have a reduced bending stiffness compared to the main tubular portion of the catheter. The intermediate portion may have a diameter reduction such that the bending stiffness of this portion is between 60% and 80% of the bending stiffness of the main tubular portion of the catheter. This reduced diameter and resulting reduced bending stiffness help prevent kinking of the catheter at the eyelet, as the deflection of the catheter will be more evenly distributed when the middle portion of the catheter is less rigid (has a lower bending stiffness) than the eyelet portion.

In an embodiment, when the catheter is straightened, the sleeve does not completely cover the insertion tip, but a tip section of at most 10mm protrudes beyond the proximal end of the handle. This has the following effect: the proximal end of the tip portion is immediately visible and insertable into the urethra while the eyelet portion with the eyelet will remain located within the handle. Having the eyelet within the protection of the handle is an advantage because the catheter is more likely to kink at the eyelet than at other cross-sections along the length of the catheter. Thus, the user can start inserting the catheter into the urethra and still support the eyelet portion of the catheter by squeezing the handle into contact with this portion.

The handle may have a soft proximal end. When performing catheterization, the soft proximal end of the handle prevents irritation of the glans of the penis if the handle is in contact with the glans. This may be accomplished by providing the proximal end of the handle with a sealing ring of, for example, a thermoplastic elastomer (TPE). Another or additional way of doing this is to provide the entire outer surface of the handle with a soft material and provide a polypropylene (PP) inner support section. In an embodiment, the handle has a TPE outer surface and a PP inner support portion including a threaded surface. The handle may then be pressed into contact with the catheter surface so that the catheter can be easily handled through the cannula.

The connector may include an inner connector portion and an outer connector portion. This allows a standard internal connector to be used as an outlet which allows connection to a urine bag. As one example, the inner connector may be made of polyurethane. The external connector portion may be made of polyethylene such as HDPE. In an embodiment, the connector and the handle are adapted to be screwed together, the outer connector part supporting the screw thread so as to be rigid enough to support the screw thread. The two connector portions may be configured to be friction fit, press fit, or snap fit together.

Embodiments are directed to catheter assemblies in which the connector forms a drainage structure that provides drainage of liquid (activation medium) from the cavity in an open configuration and does not provide drainage in a closed configuration.

In other words, when the connector and handle are separated from each other and the catheter assembly is in a use condition, liquid can be expelled from the assembly through the drain in the connector, while liquid is prevented from being expelled from the assembly in a storage condition. When using catheters, it is advantageous to properly handle and dispose of the liquid (typically about 15 ml).

The catheter assembly connector is capable of being formed into a closed configuration and an open configuration. In the closed configuration, the connector and the handle may be attached to each other such that the catheter is fully enclosed within the cavity formed by the sleeve, the handle and the connector. This is achieved by looping or coiling the assembly so that the connector and handle meet and can be attached.

The connector forms a venting structure that provides venting of fluid from the cavity in an open configuration and does not provide venting in a closed configuration. Typically, the drainage structure is a hole that extends through the connector and allows drainage of liquid from the cavity in the open configuration. The venting feature may be located in an interlock arrangement of the connector.

In a particular embodiment, the connector comprises an inner connector and an outer connector, the inner and outer connectors being separated by a liquid channel, wherein the drainage structure is present in the inner connector. In this embodiment, the external connector may comprise said interlocking means.

By means of the drainage structure, liquid in the form of an activation medium can be drained from the distal end of the catheter. The activation medium may be discharged into a toilet. The distal end of the catheter may be connected to a urine bag or hose for disposal, as described above.

Embodiments are also directed to a method of preparing a urinary catheter for insertion, the method comprising the steps of:

-providing the catheter assembly in the closed configuration;

-releasing the connector and handle from each other to form an open configuration;

-draining liquid from the cavity through the drain structure.

Embodiments are directed to providing the catheter assembly described above in a rolled configuration. The rolled configuration refers to the catheter being rolled up at least two convolutions. Providing the catheter in a rolled configuration during storage has the effect that the catheter is more compact during storage.

Embodiments include kits of parts comprising a catheter having a standard connector and a cannula having a connector portion at a distal end adapted to mate with the standard connector of the catheter (as described above). The cannula comprises the handle. The catheter may be provided with a hydrophilic coating as described above. The handle and connector may be mated as described above.

The catheter assembly may advantageously be delivered to the user in a rolled configuration with the connector attached to the handle. When the user wants to use the catheter, the catheter enclosed in the sleeve can first be taken out of the storage package, provided the storage package. The connector is separate from the handle and, in some embodiments, the activation medium is expelled from the cannula through the venting feature described above. In some embodiments, the cannula is reclosable, and the assembly may be held in a bag or pocket for later disposal. In some embodiments, it is possible to restock the catheter assembly in the storage package and reseal the storage package, as described above.

Detailed description of the drawings

The embodiments and features of the various exemplary embodiments described in this application may be combined ("mixed and matched") with each other, unless specifically noted otherwise.

Fig. 1 shows a cross-sectional view of an embodiment of a ready-to-use catheter assembly 1. The catheter assembly 1 comprises a urinary catheter 2 extending from an insertion proximal end 3 to a distal end comprising an outlet 4. The proximal end 3 includes a tip portion 5 having an eyelet 6 for passing urine into the catheter. The assembly 1 further comprises a sleeve 7 extending between the handle 8 and the connector 9. The sleeve 7 is collapsible when the handle 8 is slid along the catheter 2 (e.g. during insertion). The connector 9 comprises first snap-fitting means 10 configured for mating with complementary second snap-fitting means 11 on the handle. The second snap-fitting means 11 may be in the form of a resilient flange configured to catch behind the first snap-fitting means in the form of a flange 10 on the connector.

Fig. 2 shows a top view and fig. 3 shows a cross-sectional view of an embodiment of the catheter assembly 1 in a storage state. When stored, the connector 9 is attached to the handle 8 and the catheter 2 is thus completely enclosed or enclosed in the cavity provided by the cannula 7, the connector 9 and the handle 8.

Fig. 4 shows an embodiment of the catheter assembly 1 packaged and stored in a storage package 20. In this embodiment, the storage package 20 is made of a foil material welded along the edges to provide an enclosure 21 in which the catheter (not visible) comprising the cannula 7 is stored during storage.

Fig. 5 to 8 show an embodiment of a detail of the attachment between the connector 9 and the handle 8. Fig. 5 and 7 show perspective views of the attachment in the attached and unattached configurations, respectively. Fig. 6 and 8 show cross-sectional views of the attachment in the attached and unattached configurations, respectively.

Fig. 5 and 6 illustrate how the handle 8 and connector 9 are attached to each other to provide a closed connection and to provide a storage cavity for the head portion 5. Fig. 5 shows a view of the closed connection from the outside and fig. 6 shows a cross-sectional view of the closed connection. Also shown in fig. 6 are first and second snap-fit means 10 and 11.

Fig. 7 and 8 show the handle 8 and the connector 9 in an unattached configuration. In fig. 7, the handle 8 and the connector 9 are illustrated in a side view, and in fig. 8 a cross-sectional view thereof is illustrated. The second snap-fit means 11 on the handle provides the possibility to attach the handle to the connector. Fig. 8 also shows a tip portion 5 in the form of a flexible tip. The flexible tip has a proximal bulbous portion 12 and an intermediate portion 13 immediately distal to the bulb, wherein the diameter is reduced relative to the main tubular portion 14 of the catheter.

Fig. 9 illustrates another embodiment of the connection between the handle 8 and the connector 9 in an unattached configuration. In this embodiment, the handle and the connector are connected by a threaded coupling. In this embodiment, the external thread 15 is located at the connector 9 and the internal thread 16 is located at the handle 8. The handle 8 may be provided with a soft proximal end 17, for example made of a soft material. In the illustrated embodiment, the outer material 18 of the handle covers the handle from the distal end to the proximal end, while the inner material is only present in the central portion of the handle. Thus, the distal and proximal ends of the handle are not supported by the internal material and are therefore softer and more compliant.

Fig. 10 and 11 show an embodiment of the catheter assembly 1 in a rolled up configuration with two convolutions. In fig. 10, the catheter assembly is shown in a storage package 22. The storage package 22 provides an enclosure 23 for the urinary catheter. Fig. 11 shows the catheter assembly 1 in a rolled-up configuration without a storage package.

Fig. 12 shows an embodiment of the catheter assembly 1 ready for use, with the handle 8 and the connector 9 separated from each other and ready for insertion of a catheter. The sleeve 7 can be seen as covering a substantial part of the entire length of the catheter 2.

The embodiment of figure 13 incorporates a vent structure 30 in the form of one or more passages through the connector 9. It can be seen that any liquid present in the cavity formed by the connector 9, the cannula 7 and the handle 8 can drain from the assembly through the connector 9 when the assembly is in use or in an open configuration.

Fig. 14 shows a specific embodiment, wherein the connector 9 comprises an inner connector 31 and an outer connector 32. The inner and outer connectors (31, 32) are separated by a passage 33 for liquid, wherein the drainage structure 30 is present in the inner connector 31.

Claims

1. A catheter assembly, the catheter assembly comprising: a urinary catheter having a hydrophilic surface, said urinary catheter having an insertion tip at a proximal end of said urinary catheter and an outlet at a distal end of said urinary catheter; a handle slidably disposed on the urinary catheter; a collapsible flexible sleeve attached to the handle and configured for covering the catheter from the outlet to the insertion tip in an extended configuration of the catheter assembly, the sleeve being attached to a connector at the outlet, the connector and the handle being configured to be detachably attached to each other and defining a cavity enclosing the entire catheter in a stored state, wherein the handle has a soft proximal end, the outer material of the handle covering the handle from the distal end of the handle to the proximal end of the handle, and the inner material of the handle being present only in a central portion of the handle.

2. The catheter assembly of claim 1, wherein the connector and the handle are provided with interlocking means.

3. A catheter assembly according to claim 2, wherein said interlocking means is provided by first snap-fit means on said connector and second snap-fit means on said handle, said first and second snap-fit means being complementary snap-fit means.

4. A catheter assembly as claimed in claim 2 wherein the interlocking means is in the form of a threaded coupling.

5. The catheter assembly of any one of claims 1-4, wherein the connector is configured to receive and protect the insertion tip of the urinary catheter in the storage state.

6. The catheter assembly of any one of claims 1-4, wherein the material of the sleeve is liquid impermeable and configured for storing liquid within the sleeve in the storage state of the catheter assembly.

7. The catheter assembly of any one of claims 1-4, wherein the insertion tip is a flexible tip.

8. The catheter assembly of any one of claims 1-4, wherein the connector is provided with an inner connector portion and an outer connector portion.

9. The catheter assembly of any one of claims 1-4, wherein in the storage state the catheter assembly is arranged in a rolled configuration such that the catheter is wound with at least two convolutions.

10. The catheter assembly of any of claims 1-4, wherein the connector forms a drainage feature that provides drainage of fluid from the cavity in a use state and does not provide drainage in the storage state.

11. The catheter assembly of any one of claims 1-4, wherein the connector comprises an inner connector and an outer connector separated by a passage for fluid, wherein a drainage feature is provided in the inner connector.

12. A kit comprising a catheter assembly according to any of claims 1-11, said kit further comprising a urine collection bag and a tube connecting said urine collection bag to said connector on said catheter assembly.

13. A kit of parts as claimed in claim 12, wherein the catheter assembly is provided with interlocking means in the form of a threaded coupling and the tube is provided with a threaded coupling adapted to cooperate with the threaded coupling on the connector.

14. A kit of parts comprising a catheter assembly according to any of claims 1-11, said catheter assembly having a catheter with a standard connector and a sleeve with a connector part at a distal end, said connector part being adapted for fitting onto said standard connector of said catheter.

15. A kit of parts comprising a catheter assembly according to any one of claims 1 to 11, the kit of parts further comprising a storage package of a water vapour impermeable material.

16. A kit of parts as claimed in claim 15, wherein the storage package is reclosable.

17. A kit of parts as claimed in any one of claims 15 and 16, wherein the storage wrapper comprises a plurality of catheter assemblies.

18. A method of preparing a urinary catheter for insertion, the method comprising the steps of:

-providing a catheter assembly according to any of claims 1-11 in a storage state;

-releasing the connector and the handle from each other to form a use state;

-discharging fluid from the cavity.

19. The method of claim 18, wherein the venting is accomplished through the connector, the connector forming a venting structure that provides venting of fluid from the cavity in a use state and does not provide venting in a storage state.